The present disclosure relates to delivery devices for implanting transcatheter valves. More particularly, it relates to catheter-based delivery devices and methods for implanting a prosthetic heart valve with controlled release of the prosthesis from the delivery device.
Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heat valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.
More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of the valve prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable prosthetic valve is compressed about or within a catheter, inserted inside a lumen within the patient, such as the femoral artery, and delivered to a desired location in the heart.
The heart valve prosthesis employed with catheter-based, or transcatheter, procedures generally includes an expandable multi-level frame or stent that supports a valve body having a plurality of leaflets. The frame can be contracted during percutaneous transluminal delivery, and expanded upon deployment at or within the native valve. One type of valve stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed about a balloon portion of a catheter. The balloon is subsequently inflated to expand and deploy the prosthetic heart valve. With other stented prosthetic heart valve designs, the stent frame is formed to be self-expanding. With these systems, the valved stent is crimped down to a desired size and held in that compressed state within a sheath for transluminal delivery. Retracting the sheath from this valved stent allows the stent to self-expand to a larger diameter, fixating at the native valve site.
The actual shape or configuration of any particular transcatheter prosthetic heart valve is dependent, at least to some extent, upon the valve being replaced or repaired (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). The stent frame must oftentimes provide and maintain (e.g., elevated hoop strength and resistance to radially compressive forces) a relatively complex shape in order to achieve desired fixation with the native anatomy. With self-expanding stent designs, the stent frame can experience significant, rapid radial expansion upon deployment from the sheath. Taken in combination, these design features can give rise to delivery concerns. A rapidly expanding stent having one section expanding to a substantially larger diameter than an adjacent section can cause the prosthetic heart valve to spring off a valve retainer of the delivery device in a relatively un-controlled fashion. This rapid deployment can, in turn, result in the valve section(s) forcing itself past or beyond the intended anatomical location. For example, exemplary prosthetic mitral valve designs can have an inflow diameter on the order of 60 mm, with the inflow section of the stent frame being perpendicular, or nearly perpendicular, to a shape of the outflow section. During transluminal delivery to the native mitral valve, the stent frame is crimped down to a nearly cylindrical shape, having a diameter on the order of 12 mm. The inflow section of the prosthetic mitral valve is intended to self-engage the native annulus, can experience rapid, uncontrolled expansion upon deployment, and may instead thrust past the native annulus and into the left ventricle.
Although there have been multiple advances in transcatheter prosthetic heart valves and related delivery systems and techniques, there is a continuing need to provide different delivery tools for controlled deployment of the prosthesis.